Tarceva First Generation TKI for EGFR + Non Small Cell Lung Cancer

Tarceva Outperforms Chemotherapy for Initial Treatment of Lung Cancer with an EGFR Mutation.

Among patients with advanced non-small cell lung cancer that tests positive for a mutation in the EGFRgene, initial treatment with the targeted therapy Tarceva® (erlotinib) produces better outcomes and fewer serious side effects than chemotherapy. These results were published in Lancet Oncology.

As cancer research has evolved, it’s become apparent that the specific characteristics of a tumor can have a profound effect on the behavior of the cancer and its response to particular treatments. In the case of non-small cell lung cancer (NSCLC), for example, mutations in the EGFR (epidermal growth factor receptor) gene may influence whether the cancer responds to the EGFR-targeted drugs like Tarceva. Tarceva is currently approved for the treatment of advanced NSCLC and as maintenance therapy after chemotherapy.

To compare Tarceva with chemotherapy for the initial treatment of advanced NSCLC that tests positive for an EGFR mutation, researchers conducted a study among 165 patients with Stage IIIB or Stage IV NSCLC. Half the patients were treated with Tarceva and half were treated with combination chemotherapy consisting of Gemzar® (gemcitabine) and carboplatin.

  • Treatment with Tarceva substantially delayed cancer progression. Median survival without cancer progression was 13.1 months among patients treated with Tarceva and 4.6 months among patients treated with chemotherapy.
  • Serious side effects were also less common in the Tarceva group.

These results suggest that for patients with advanced NSCLC that tests positive for an EGFR mutation, initial treatment with Tarceva is more effective and better tolerated than chemotherapy.

Tarceva Effective as Maintenance Therapy in NSCLC

The safety and effectiveness of Tarceva maintenance therapy was evaluated in a Phase III clinical trial known as SATURN. Maintenance therapy refers to treatment that is given after initial treatment but before cancer progression. It is a relatively new approach to lung cancer treatment.

The study enrolled more than 880 patients with advanced NSCLC that had not progressed following initial, platinum-based chemotherapy. Half the patients received Tarceva maintenance therapy, and half received a placebo.

  • Compared with a placebo, overall survival was 23% better among patients treated with Tarceva, and progression-free survival was 41% better.
  • The most common side effects among patients treated with Tarceva were rash (49%) and diarrhea (20%).

Based on these results, the FDA expanded the approval of Tarceva to include maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer that has not progressed after four cycles of platinum-based first-line chemotherapy.

Reference: OSI Pharmaceuticals. FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-small Cell Lung Cancer. Available at: . Accessed April 19, 2010.

Reference: Zhou C, Wu Y-L, Chen G et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): A multicentre, open-label, randomized, phase 3 study. Lancet Oncology. Early online publication July 22, 2011.

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